FDA UDI
In Commercial Distribution
🇺🇸 United States
BiliChek
DI: 00884838096578
·
Model: Bilical, 50 Pack
·
Philips Medical Systems Hsg
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- BiliChek
- Primary DI
- 00884838096578
- Version / Model
- Bilical, 50 Pack
- Catalog Number
- B800-50
- Company Name
- Philips Medical Systems Hsg
- Labeler DUNS
- 790605856
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-10-21
- Public Version
- 1
- Public Version Date
- 2022-10-31
- Public Version Status
- New
- Public Device Record Key
- cd05c9a5-279b-4230-bd45-4652bcedf086
Device Description
Bilical, 50 Pack
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQM | Bilirubin (Total And Unbound) In The Neonate Test System | Clinical Chemistry | 862.1113 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16166 | Transcutaneous bilirubinometer | A noninvasive, battery-powered, hand-held, portable instrument intended to measure transcutaneous bilirubin (TcB) levels, in order to predict total serum bilirubin (TSB) levels in a neonate. It directs a light beam into the newborn’s skin, usually on the forehead, sternum or ear, and measures the intensity of multiple wavelengths (typically 2 or more) that are reflected from the newborns subcutaneous tissue. These optical signals are processed (typically by a photocell and microprocessor) to give a TcB and/or TSB value. It is used mainly for screening hyperbilirubinemia. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 30884838096579 | GS1 | ||||
| Primary | 00884838096578 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 86 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity